NCT05909436招募中1 期
A Phase I/II Study Evaluating the Safety, Tolerability and Preliminary Efficacy of GLS-012 Monotherapy and in Combination With GLS-010 in Patients With Advanced Solid Tumors After Progression on Standard Treatment (Triumph-01)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Number of Participants with a Dose-Limiting Toxicity (DLT) and MTD in the dose escalation stage
研究概览
简要总结
This is a phase I/II study to investigate the safety, tolerability, and preliminary efficacy of GLS-012 monotherapy and in combination with GLS-010 in subjects with advanced solid rumor after progression on standard treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are willing to sign the informed consent form;
- •Aged 18-75 years, male or female;
- •Histologically confirmed diagnosis of a solid tumor;
- •Patients with advanced solid tumors after progression on standard treatment;
- •Subjects must have at least 1 measurable target lesion according to RECIST version 1.1；
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1；
- •Life expectancy more than 12 weeks;
- •Adequate organ function and bone marrow function as indicated by the screening assessments in the screening period;
- •Women of childbearing potential must use highly effective contraception during the study period and at least 6 months after the last study drug administration, and must have a negative blood pregnancy test within 3 days before study enrollment.
排除标准
- •Patients with irAEs of grade ≥ 3 in the previous immunotherapy, and the AEs of the last anti-tumor treatment have not recovered to grade ≤ 1, except for hypothyroidism/hyperthyroidism and dermatitis that have recovered to grade ≤ 2, and AEs with no safety risks judged by the investigators, for example, alopecia.
- •Patients with primary or secondary immunodeficiency, or patients who are receiving long-term systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before randomization.
- •Use of corticosteroids or other immunosuppressants for systemic treatment within 14 days before the first study drug administration;
- •Known central nervous system (CNS) metastases;
- •Patients with severe hypersensitivity to macromolecular protein preparations/monoclonal antibodies in the past.
- •Patients with other malignant tumors within 5 years before screening, except cured cervical carcinoma in situ and cured skin basal cell carcinoma.
- •Cardiac clinical symptoms or diseases that are not well controlled.
- •Known hereditary or acquired bleeding and thrombosis tendency.
- •Patients with congenital or acquired immunodeficiency disorders (such as HIV-infection), or a history of organ transplantation.
- •Patients complying with any of hepatitis B surface antigen (HBsAg) positive and HBV-DNA copies being more than 2500 copies/ml (or 500 IU/ml); or positive HCV-RNA;
- •Patients with poor compliance or other conditions that are not suitable to participate in the clinical trial, as considered by the investigator.
研究组 & 干预措施
Dose escalation and expansion of GLS-012 monotherapy and combination with GLS-010
Experimental
干预措施: GLS-012 (Drug)
Dose escalation and expansion of GLS-012 monotherapy and combination with GLS-010
Experimental
干预措施: GLS-010 (Drug)
结局指标
主要结局
Number of Participants with a Dose-Limiting Toxicity (DLT) and MTD in the dose escalation stage
时间窗: Up to 21 days after the first dose
Number of participants with treatment-related adverse events of GLS-012 monotherapy and in combination with GLS-010 in the expansion stage as assessed by CTCAE V5.0
时间窗: Up to approximately 24 months
次要结局
- Objective response rate (ORR)(Up to approximately 24 months)
- Disease control rate (DCR)(Up to approximately 24 months)
- Preliminary anti-tumor activity: Duration of response (DOR), time to response (TTR), progression free survival (PFS), overall survival (OS)(Up to approximately 24 months)
- Maximum plasma concentration (Cmax) of GLS-012 monotherapy and in combination with GLS-010(Up to approximately 4.5 months)
- Elimination half-life (T1/2) of GLS-012 monotherapy and in combination with GLS-010(Up to approximately 4.5 months)
- Overall survival (OS)(Up to approximately 24 months)
- Time to response (TTR)(Up to approximately 24 months)
- Duration of response (DOR)(Up to approximately 24 months)
- Progression free survival (PFS)(Up to approximately 24 months)
研究者
研究点 (1)
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